MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-28 for TSB GROWTH MEDIA 100 ML * manufactured by Q.i. Medical, Inc..
[20762776]
Using q. I. Medical, inc, tsb growth media, 100 ml, as qa process validation tool. Media was found to have inanimate sterile filaments floating in it that invalidate results of test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025181 |
| MDR Report Key | 397240 |
| Date Received | 2002-05-28 |
| Date of Report | 2002-05-28 |
| Date of Event | 2002-05-28 |
| Date Added to Maude | 2002-06-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TSB GROWTH MEDIA 100 ML |
| Generic Name | GROWTH MEDIA |
| Product Code | JSD |
| Date Received | 2002-05-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 010076 |
| ID Number | * |
| Device Expiration Date | 2003-03-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 386293 |
| Manufacturer | Q.I. MEDICAL, INC. |
| Manufacturer Address | 111-B NEW MOHAWK RD NEVADA CITY CA 95959 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-28 |